Clinical Trial Protocol Development

Every clinical investigation begins with the development of a clinical protocol. The protocol is a document that describes how a clinical trial will be conducted (the objective(s), design, methodology, statistical considerations and organization of a clinical trial,) and ensures the safety of the trial subjects and integrity of the data collected.

A research protocol is a document that describes the background, rationale, objectives, design, methodology, statistical considerations, and organization of a clinical research project. According to the ICH Good Clinical Practice guidelines, a protocol should include the following topics:

Title Page (General Information)

Background Information

Objectives/Purpose

Study Design

Selection and Exclusion of Subjects

Treatment of Subjects

Assessment of Efficacy

Assessment of Safety

Adverse Events

Discontinuation of the Study

Statistics

Quality Control and Assurance

Ethics

Data handling and Recordkeeping

Publication Policy

Project Timetable/Flowchart

References

Supplements/Appendices

The NIH provides many resources for protocol development to assist investigators in writing and developing clinical research protocols that are in compliance with regulatory/GCP requirements. Some NIH institutes have a mandatory requirement for using their protocol template.